Actively Recruiting
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
Led by OncoC4, Inc. · Updated on 2026-04-13
72
Participants Needed
8
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.
CONDITIONS
Official Title
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status score of 0 or 1
- Body weight of at least 40 kilograms
- Histological or cytological diagnosis of solid tumors with metastatic or locally advanced disease
- Presence of measurable target lesion according to RECIST V1.1 criteria
- Adequate organ function based on laboratory tests
- Voluntary written informed consent to participate
- Female participants must have a negative pregnancy test and agree to use contraceptive methods
- Male participants must agree to use contraceptive methods
- Agreement to provide archival or diagnostic tissue slides or optional new tumor biopsy
You will not qualify if you...
- Not recovered to grade 1 or less adverse event from prior cancer treatment, except controlled chemotherapy-related neuropathy or alopecia
- Insufficient washout period from prior cancer therapies (less than 5 half-lives or 21 days for chemotherapy, or 28 days for monoclonal antibodies)
- Palliative radiotherapy within 7 days before first study drug dose
- Participation in other clinical trials with investigational agents or concurrent anticancer treatments (except palliative bone radiotherapy)
- Chronic systemic steroid use above 10 mg/day prednisone or equivalent within 7 days before first treatment
- Active brain or leptomeningeal metastases unless treated, stable, asymptomatic, and off steroids for 14 days
- Other cancers requiring systemic treatment within 24 months prior to first dose
- History of severe allergic reactions to IV medications or related conditions requiring hospitalization
- Significant cardiovascular events or severe immune-related adverse events within 6 months
- Acute infections requiring systemic treatment within 14 days before first dose
- Conditions or abnormalities that might interfere with study participation or results as judged by investigator
- Known psychiatric or substance abuse disorders that impair cooperation
- Pregnancy, breastfeeding, or planning pregnancy/fathering during study or within 6 months after last dose
AI-Screening
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Trial Site Locations
Total: 8 locations
1
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
UF Health Cancer Center, University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
3
AdventHealth Medical Group Oncology Research at Celebration
Kissimmee, Florida, United States, 34747
Actively Recruiting
4
Norton Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
Rogel Cancer Center, University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 770360
Actively Recruiting
8
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
Research Team
P
Pan Zheng, MD, PhD
CONTACT
I
Imaan Khan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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